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  • Clinical Laboratory Improvement Amendments (clia) Application For Certification - Azdhs

Get Clinical Laboratory Improvement Amendments (clia) Application For Certification - Azdhs

Aug 12, 2015 ... Quality Assurance Division, Certification Bureau 2401 Colonial Drive, ... you need to apply for a CLIA Certificate on a CMS-116 form ... How to Apply for a CLIA Certificate tab or.

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How to fill out the Clinical Laboratory Improvement Amendments (CLIA) Application For Certification - Azdhs online

This guide provides clear and comprehensive instructions for completing the Clinical Laboratory Improvement Amendments (CLIA) Application For Certification through an online format. By following the steps outlined below, users can ensure that their application is filled out accurately and efficiently, facilitating the certification process for their laboratory.

Follow the steps to complete the CLIA application online.

  1. Click ‘Get Form’ button to obtain the form and open it in the editor.
  2. Begin by completing the general information section. Indicate whether you are submitting an initial application, survey, or any changes in certificate type. Provide the facility name, federal tax identification number, email address, telephone number, and physical address of the laboratory.
  3. For the type of certificate requested, check the box corresponding to the highest level of testing your laboratory performs, such as a certificate of waiver or accreditation.
  4. In the type of laboratory section, select the option that best describes your facility's operation, ensuring to check if it is a shared lab if applicable.
  5. Specify the hours of laboratory testing for each day of the week using the HH:MM format or check the box for 24/7 operations.
  6. If you are applying for a single-site CLIA certificate to cover multiple testing locations, complete the related section by indicating the applicable regulatory exceptions.
  7. In the waived testing section, describe the specific waived tests performed and estimate the total annual test volume.
  8. For PPM testing, similarly specify the PPM tests and estimated annual test volume.
  9. In the non-waived testing section, detail all non-waived tests performed, including estimated annual test volumes for each specialty.
  10. Complete the type of control section by selecting the relevant ownership type of your laboratory.
  11. If the laboratory director operates additional laboratories, provide the necessary details in the director affiliation section.
  12. Carefully review all provided information for accuracy and completeness. Once verified, save your changes and proceed to download, print, or share your application as needed.

Complete your CLIA application online today to ensure your laboratory's compliance and operation.

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The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.

Who provides reimbursement for laboratory tests on the certificate of waiver list? Laboratory tests on the certificate of waiver list may be billed to Medicare and Medicaid for reimbursement.

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

CLIA applies to all entities providing clinical lab services and requires these labs meet applicable federal requirements and have a current CLIA certificate, including those that don't file Medicare test claims. CLIA requirements also apply to labs in physician offices.

You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available on the CMS CLIA website or from your local State Agency. Send your completed application to the address of the local State Agency for the State in which your laboratory is located.

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

Certificate of Waiver – This certificate is issued to a laboratory to perform only waived tests.

As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer's applications for test system waiver.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232